FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8 Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activity Company has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated... Read More

Webcast set for 8:30 a.m. ET on December 3rd SALT LAKE CITY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced... Read More

SALT LAKE CITY, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the... Read More

SALT LAKE CITY, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

Late-breaking clinical data presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis Across non-active progressive MS (primary progressive and secondary progressive MS), relapsing MS, and Parkinson’s disease patients, CNM-Au8 ® improved the brain’s energy metabolism evidenced by improved NAD+/NADH ratio At the Type B end-of-Phase 2 MS meeting with the U.S. Food and Drug... Read More

Novel human preclinical neuronal model for Parkinson’s disease demonstrated CNM-Au8’s ability to improve mitochondrial health, restore cellular metabolism, reduce inflammation, and normalize dysregulated gene expression in both familial and sporadic Parkinson’s disease Results presented today at the H2 Therapeutics Stewardship Meeting in New York City, hosted by the Michael J Fox Foundation Taken together with results from a... Read More

SALT LAKE CITY, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the H.C.... Read More

Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025 A second Type C meeting has been scheduled with the FDA in the third quarter of 2025 to review the survival benefit associated with CNM-Au8 dosing The Company expects to submit a New Drug Application in the... Read More

SALT LAKE CITY, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Canaccord... Read More

FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene’s NIH-sponsored Expanded Access Program NfL EAP biomarker analyses to be conducted early in the 4 th Quarter of 2025 Clene confirms two additional FDA meetings scheduled for 3 rd Quarter of 2025, to discuss ALS survival data and MS clinical development program Submission of new drug application for ALS under... Read More

SALT LAKE CITY, UT / ACCESS Newswire / June 9, 2025 / Clene Inc. announced that Rob Etherington, Chief Executive Officer and President, will be presenting at the Investor Summit Virtual taking place on June 10. About Clene Inc. Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving... Read More

Salt Lake City, Utah--(Newsfile Corp. - May 7, 2025) - Clene Inc. (NASDAQ: CLNN), today announced its participation in the D. Boral Capital Inaugural Global Conference, taking place May 14, 2025, at The Plaza Hotel in New York City. Rob Etherington, President and Chief Executive Officer, will be hosting one-on-one meetings on May 14th from 9:00 A.M. to 3:00 P.M. (ET). To register for one-on-one meetings with management at... Read More

Clene preparing for upcoming meeting in the second quarter with the U.S. Food and Drug Administration (FDA) to reach agreement on its statistical analysis plan (SAP) regarding analysis of neurofilament light chain (NfL) biomarker data Clene collecting NfL biomarker data from its large National Institute of Health (NIH)-sponsored Expanded Access Protocol (EAP), for evaluation in the third quarter to satisfy the FDA... Read More

SALT LAKE CITY, April 14, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Emerging Growth... Read More

Analyses of MRI and VEP data confirm anatomical and physiological improvements, indicating remyelination and neuronal repair in the brains of MS patients treated with CNM-Au8 during the long-term extension of VISIONARY-MS Over 90% of participants who showed improvements in cognition and vision also demonstrated corresponding improvements on MRI and visual electrophysiology tests SALT LAKE CITY, April 08, 2025 (GLOBE... Read More

SALT LAKE CITY, April 01, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will present at the Jones... Read More

Clene planning to submit a New Drug Application (NDA) in the second half of 2025 for potential Accelerated Approval of CNM-Au8 ® in ALS Clene planning to initiate the confirmatory Phase 3 RESTORE-ALS trial in subjects with ALS in mid-2025 Secured new $10.0 million debt facility at a lower interest rate to replace remaining outstanding $7.85 million debt balance with Avenue Capital Cash, cash equivalents and marketable... Read More

SALT LAKE CITY, March 12, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced new evidence from a cross-regimen, post hoc analysis of long-term survival in HEALEY ALS Platform... Read More

SALT LAKE CITY, March 06, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that management will participate in a... Read More

Longitudinal ALS patient data from APST Research will enable a more robust analysis of the effect of CNM-Au8 on NfL biomarkers APST Research data includes thousands of people living with ALS including clinical, survival, and longitudinal NfL data Clene plans to analyze the APST ALS NfL biomarker and clinical dataset to compare NfL change from its ongoing NIH-sponsored EAP to address the FDA’s request for supportive evidence... Read More

Secures new $10.0 million debt facility to replace remaining $7.85 million of Avenue Capital debt Improves cash position enabling Clene to generate the additional data to support the new drug application of CNM-Au8 ® for ALS via an accelerated regulatory pathway Carries a 12% interest rate per annum and is secured by all assets of Clene Includes conversion feature on 65% of the new debt facility at a fixed conversion price... Read More

FDA recommends that Clene leverage additional Neurofilament Light (NfL) data from its three Expanded Access Protocols (EAPs) and the HEALEY ALS Platform Trial to support earlier presented findings FDA recommends a follow-up meeting to discuss in more detail the analyses needed to support the accelerated approval pathway Additional NfL biomarker collection and analyses are underway and planned to be completed during the... Read More

Clene met with the U.S. Food and Drug Administration (FDA) on November 1, 2024, in a Type C meeting to discuss the potential for an accelerated approval pathway in ALS and are awaiting meeting minutes Cash, cash equivalents and marketable securities of $14.6 million as of September 30, 2024 Amended debt agreement with Avenue Capital to defer principal payments and extend maturity of facility to second quarter of 2025... Read More

SALT LAKE CITY, Oct. 09, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it will... Read More

Investment led by healthcare-focused institutional investor with participation from SymBiosis; founding investor Kensington Capital Holdings; Clene’s Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific Officer and Founder; along with support from several other previously existing shareholders $7.3 million registered direct offering and concurrent private placements priced at market under Nasdaq... Read More

SALT LAKE CITY, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly-owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurological diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that on... Read More

SALT LAKE CITY, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), announced today that... Read More

SALT LAKE CITY, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

Survival analyses with CNM-Au8 ® 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival... Read More

CNM-Au8 treated participants in the HEALEY ALS Platform Trial with substantial neurofilament light (NfL) declines (CNM-Au8 NfL Responders) demonstrated significant clinical improvements in survival, functional status (slowed ALSFRS-R decline), and combined function and survival (CAFS scores) compared to NfL non-responders Independent of NfL responder status, significant survival benefits in CNM-Au8 30mg treated participants... Read More

SALT LAKE CITY, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

SALT LAKE CITY, July 12, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

SALT LAKE CITY, July 11, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced plans to... Read More

SALT LAKE CITY, July 09, 2024 (GLOBE NEWSWIRE) -- Clene Inc . (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it... Read More

SALT LAKE CITY, June 24, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

CNM-Au8 demonstrated neuroprotective effects in an in vitro model of Rett Syndrome, a rare pediatric neurodevelopmental disease CNM-Au8 also demonstrated rescue of mitochondrial deficits in induced astrocytes derived from Rett patients Invited oral presentation and poster presented on June 19, 2024, at the International Rett Syndrome Foundation 2024 Annual Meeting in Westminster, Colorado SALT LAKE CITY, June 21, 2024 (GLOBE... Read More

Survival analyses with CNM-Au8 30 mg treatment compared to matched PRO-ACT controls demonstrated improved survival up to 3.5 years post-baseline (hazard ratio: 0.431, p=0.0002) Average of 28% NfL reduction observed in an NfL responder subset (geometric mean ratio, change at Week 76 post-baseline: 0.72, p<0.0001) More than 650 patient years of CNM-Au8 treatment exposure without any identified safety signals SALT LAKE CITY,... Read More

SALT LAKE CITY, June 05, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that... Read More

First patient, first visit is planned for early June 2024 Enrollment has been expanded by 80% to a maximum of 180 participants ‘Real-world’ drug efficacy data will be collected by monitoring potential drug effects on survival and disease progression, as well as safety SALT LAKE CITY, May 28, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly-owned subsidiary Clene... Read More

SALT LAKE CITY, May 14, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis and multiple sclerosis, today announced that it will... Read More

Data from long-term extension of Phase 2 VISIONARY-MS clinical trial of CNM-Au8 ® demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05) Peer-reviewed publication characterized the protein corona of CNM-Au8 Company received sub-award of $7.3 million from NIH grant for ALS Expanded Access Program Cash, cash equivalents and marketable... Read More

Long term extension of the Phase 2 VISIONARY-MS clinical trial of CNM-Au8 demonstrated significant evidence of repair and remyelination across multiple paraclinical endpoints (change from original baseline, p<0.05) Significantly improved clinical outcomes associated with long-term daily oral CNM-Au8 ® 30 mg treatment (change from original baseline; p<0.05) Long-term CNM-Au8 treatment, encompassing up to three years, was... Read More

LOS ANGELES, March 19, 2024 (GLOBE NEWSWIRE) -- via IBN – IBN, a multifaceted communications organization engaged in connecting public companies with the investment community, today announces that Rob Etherington, President, Director and CEO of late clinical-stage biopharmaceutical company Clene Inc. (NASDAQ: CLNN), recently appeared on First in Human, a biotech-focused podcast featuring interviews with industry leaders and... Read More

Proprietary catalytic gold nanocrystals comprising Clene’s investigational drug CNM-Au8 ® develop a protein corona upon exposure to human blood plasma comprised of proteins that promote blood-brain barrier penetration, an important feature of the drug’s neuroprotective mechanism of action The protein corona attracted by CNM-Au8 nanocrystals prevents aggregation upon entering the bloodstream, enabling the drug’s longevity in... Read More

Initiated discussions with FDA regarding accelerated approval pathway for CNM-Au8 ® for the treatment of ALS with the objective of submitting an NDA in 2024 Released long-term data from the open-label extension of the HEALEY ALS Platform Trial in which CNM-Au8 demonstrated statistically significant reductions of plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomization,... Read More

SALT LAKE CITY, March 07, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced that it... Read More

Long-term CNM-Au8 treatment demonstrated significant and clinically meaningful improvement of vision as measured by low contrast letter acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from randomization, p<0.0001 Long-term CNM-Au8 treatment demonstrated improvement of cognition, measured by the Symbol Digit Modality Test (SDMT), through 35 months from... Read More

Two “Compassionate Use” Expanded Access Programs (EAPs) provided access to treatment with CNM-Au8 to more than 250 people living with amyotrophic lateral sclerosis (ALS). A significant survival benefit (p=0.0001) was observed in EAP participants treated with CNM-Au8 compared to historical ALS disease progression controls (participants untreated with CNM-Au8) in two independent analyses: a 68% decreased risk of all-cause... Read More

Long-term CNM-Au8 treatment demonstrated improvement of vision as measured by low contrast visual acuity (LCLA), an assessment of visual function in people living with multiple sclerosis (MS), through 35 months from randomization, p<0.0001 Long-term CNM-Au8 treatment demonstrated improvement of cognition, measured by the Symbol Digit Modality Test (SDMT), through 35 months from randomization, p<0.0001 Treatment was... Read More

SALT LAKE CITY, Dec. 21, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today provided an ALS... Read More

CNM-Au8 30mg treatment demonstrated significantly reduced plasma neurofilament light chain (NfL) levels at 76 weeks relative to placebo (18 months from randomization, p=0.023) 60% decreased risk of long-term all-cause mortality (>18 months, p=0.0167) in participants originally randomized to CNM-Au8 30mg compared to those originally randomized to placebo using the rank-preserving structural failure time model (RPSFTM) CNM-Au8... Read More

Journal of Nanobiotechnology publication describes results from the successful Phase 2 REPAIR clinical studies that measured changes in brain energy metabolites in multiple sclerosis and Parkinson’s disease with CNM-Au8® treatment Data show significant increase in brain NAD+/NADH ratio from baseline, the studies’ primary endpoint, following 12 weeks of daily oral dosing of CNM-Au8 CNM-Au8 treatment resulted in favorable... Read More

Reported statistically significant improved survival benefit of 19.3 months and significantly delayed clinical worsening in patients treated with CNM-Au8 ® in the RESCUE ALS open-label extension trial Reported statistically significant long-term survival benefit of 70% decreased risk of death associated with CNM-Au8 treatment in the HEALEY ALS Platform Trial compared to PRO-ACT historical controls Awarded $45.1 million NINDS... Read More

SALT LAKE CITY, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc. in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), to support an Expanded Access Protocol (EAP)... Read More

Novel catalytic mechanism of CNM-Au8 reveals its promise as a versatile new treatment to address multiple assaults on neuronal health in neurodegenerative diseases SALT LAKE CITY, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc. (collectively, “Clene”), today announced the publication of a scientific paper describing the catalytic mechanism of action of... Read More

SALT LAKE CITY, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis, today... Read More

Prolonged life with 49% decreased risk of death for participants in the HEALEY ALS Platform Trial treated with CNM-Au8 ® 30mg compared to PRO-ACT matched placebo over long-term follow-up, p=0.046 Prolonged life with 59% decreased risk of death for participants in an integrated meta-analysis across HEALEY ALS Platform Trial and RESCUE-ALS Trial with CNM-Au8 30mg compared to PRO-ACT matched placebo over long-term follow-up,... Read More

SALT LAKE CITY, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis, today... Read More

19.3 month significant survival difference for CNM-Au8 ® treated participants versus placebo 52% significant decreased risk of ALS clinical worsening events Over 475 years of CNM-Au8 treatment exposure without any identified safety signals SALT LAKE CITY, Aug. 29, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) through its wholly owned subsidiary Clene Nanomedicine Inc., today announced the 24-month long-term data cut... Read More

Reported statistically significant reductions in plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) in patients treated with CNM-Au8 ® in the HEALEY ALS Platform trial Announced publication of the results of the Phase 2 RESCUE ALS study and its open-label extension in the Lancet journal, eClinicalMedicine Received one-year grant from the National Multiple Sclerosis Society (NMSS) that will... Read More

SALT LAKE CITY, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that it will present at the Canaccord Genuity 43rd Annual Growth Conference. Rob Etherington, Chief Executive Officer, and... Read More

Peer-reviewed publication includes data from the CNM-Au8 Phase 2 RESCUE-ALS trial and its open-label-extension, up to 120 weeks of patient follow-up SALT LAKE CITY, June 26, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative... Read More

Investment led by Vivo Capital with participation from SymBiosis, Acuta Capital Partners, AIGH Capital, Serrado Capital LLC, and other new biotech investors, with support from existing insiders $40 million underwritten public offering with up to an additional potential $130.8 million in proceeds through future warrant exercises with accelerated expiration dates tied to satisfaction of regulatory milestones Aggregate... Read More

SALT LAKE CITY, June 16, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced the pricing of an underwritten public offering of (i) 50,000,000 shares of its common stock and (ii) two tranches of warrants... Read More

SALT LAKE CITY, June 15, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN), along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced a proposed underwritten public offering in which it intends to offer and sell (i) shares of its common stock and (ii)... Read More

CNM-Au8 ® treatment demonstrated significantly reduced plasma neurofilament light chain (NfL) levels compared to placebo at 24 weeks (p=0.04) Clene plans to discuss the totality of the survival and time-to-event results from the full CNM-Au8 clinical data set, including the plasma NfL biomarker data, at an upcoming FDA meeting to accelerate the path toward approval SALT LAKE CITY, June 15, 2023 (GLOBE NEWSWIRE) -- Clene Inc.... Read More

SALT LAKE CITY, June 15, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that Rob Etherington, Chief Executive Officer, will participate in a fireside chat with Naz Rahman, Senior Biotech Research... Read More

SALT LAKE CITY, May 25, 2023 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN), along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced that Clene has received a grant from the National Multiple Sclerosis Society (NMSS) via the organization’s Fast Forward... Read More

ALS biomarker and long-term clinical data expected mid-year Neurology expert Ben Greenberg, M.D., M.H.S., joined as Head of Medical SALT LAKE CITY, May 12, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today... Read More

SALT LAKE CITY, April 25, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, announced that CNM-Au8 ® results in multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) were presented in plenary sessions at... Read More

SALT LAKE CITY, April 11, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced three presentations at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, taking place April 22-27,... Read More

SALT LAKE CITY, March 16, 2023 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) along with its subsidiaries “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative disease, today announced the appointment of Benjamin Greenberg, M.D., M.H.S. as Head of Medical. An internationally recognized expert in treating... Read More

Amyotrophic lateral sclerosis (ALS): Significant survival benefits demonstrated across two ALS clinical trials, along with clinical improvements as early as six months CNM-Au8 ® associated with 74% lower risk of ALS clinical worsening events at six months supporting a survival benefit in the HEALEY ALS Platform Trial CNM-Au8 significantly preserved physical function (ALSFRS-R) from randomization to 48 weeks in the RESCUE-ALS... Read More

CNM-Au8 associated with a 74% lower risk (lower hazard ratio) of ALS clinical worsening, which included death, non-invasive ventilation >22 hours per day, tracheostomy, or feeding tube placement (p = 0.035) CNM-Au8 associated with a 98% lower risk of death or permanent assisted ventilation (p= 0.028) CNM-Au8 associated with a 74% lower risk of feeding tube placement (p= 0.035) CNM-Au8 associated with a 63% lower risk of... Read More

SALT LAKE CITY, March 08, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, announced today that it will host a live audio webcast at 7:30 a.m. ET tomorrow, Thursday, March 9, to review new clinical results from the... Read More

SALT LAKE CITY, March 07, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced that it will participate in Roth’s 35 th Annual Healthcare Conference set for March 12 th -14 th and in Renmark Financial... Read More

Significant preservation of function (ALSFRS-R) from randomization to 48 weeks (p=0.0159) Significant preservation of function (ALSFRS-R) during the long-term open-label extension (OLE) week 24 to 120 weeks from randomization (p=0.0057) Significantly reduced risk of ALS clinical worsening by 52% over 120 weeks (HR: 0.478, p=0.0494) CNM-Au8 treatment was well-tolerated without long term safety concerns SALT LAKE CITY, March... Read More

Positive clinical results demonstrated in stable relapsing multiple sclerosis patients adjunctive to immunomodulatory disease modifying therapy was previously reported Updated Visual Evoked Potential (VEP) findings provide evidence of improved information signaling from the eye to the brain’s visual cortex These significant VEP results alongside the previously reported significant MRI results add to the totality of evidence... Read More

MRI results reinforce the clinical neurological improvements previously reported MRI results showed improved brain neuronal structural integrity, independent of an immunomodulatory effect MRI results consistently favor CNM-Au8 improvement of neuronal integrity and myelin improvement, showing decreased brain deterioration The brain improvements in stable MS patients on background therapy are unprecedented SALT LAKE CITY, Feb.... Read More

SALT LAKE CITY, Jan. 11, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company today announced that it will participate in Renmark Financial Communications Inc.’s Virtual Non-Deal Roadshow Series on January 18 and January 23. The Company welcomes stakeholders, investors, and other interested... Read More

Primary endpoint of time to substantial symptom resolution was not met in acutely symptomatic, non-hospitalized COVID-19 patients CNM-ZnAg treatment was safe and well-tolerated SALT LAKE CITY, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company today announced topline study... Read More